TENAPANOR TAB

Clinical Criteria Summary

Mechanical gastrointestinal obstruction, known or suspected
Age less than 18 years
Presence of severe or frequent diarrhea
Note: For purposes of these criteria and as causes of chronic constipation, irritable bowel syndrome (IBS) excludes drug-induced chronic constipation and chronic constipation due to neurogenic and non-neurogenic disorders

Men or women 18 years or older with a documented diagnosis of irritable bowel syndrome with constipation (IBS-C)
Intolerance or inadequate response to a 1-month trial of either PEG-3350 powder for oral solution (17 g twice daily) or other osmotic laxative, unless there is a contraindication or risk factor(s) for serious adverse event(s)

For men: Intolerance or inadequate response to 1-month trials of plecanatide and linaclotide unless there is a contraindication or risk factor(s) for serious adverse event(s)
For women: Intolerance or inadequate response to 1-month trials of lubiprostone, plecanatide and linaclotide unless there is a contraindication or risk factor(s) for serious adverse event(s). Use of lubiprostone is off-label for IBS-C in men.

GI consultation (including e-consult) is highly recommended prior to using tenapanor for IBS-C
Examples of osmotic laxatives include lactulose, sorbitol, magnesium citrate, magnesium hydroxide, and glycerin rectal suppositories
During the 1-month trial, escalation/titration of therapy up to bowel-prep doses of PEG-3350 may be considered case by case to achieve the desired response

Hyperphosphatemia in end-stage CKD / End-Stage Renal Disease
Adults with stable hyperphosphatemia (4–8 mg/dL) on maintenance hemodialysis (HD) or peritoneal dialysis (PD)
Patients receiving maintenance dialysis (HD or PD) with phosphate levels >5.5 mg/dL despite phosphate binder therapy

Pediatric patients under 6 years of age
Patients with known or suspected mechanical obstruction
Risk of severe diarrhea
Diarrhea reported in approximately 50% of clinical trials as mild-to-moderate and transient, or responding to dose reduction

Can be used in addition to traditional intraluminal phosphate binding agents, though overall result may be less than fully additive (<1 mg/dL reduction in tenapanor+binder vs. placebo+binder arms)
Phosphate reduction is a surrogate endpoint; correlation to clinically important endpoints is unknown
Significantly more costly than formulary phosphate reducing agents
Different mechanism of action (NHE3 inhibitor) compared to constipating intraluminal binders; diarrhea is a common side effect